CROSS-REFERENCE TO RELATED PATENT APPLICATIONThis application is related to prior U.S. patent application Ser. No. 10/244,062 filed Sep. 16, 2002, the entire disclosure of which is incorporated herein by reference.[0001]
BACKGROUND OF THE INVENTION1. Field of the Invention[0002]
The present invention relates generally to angled tissue cutting instruments and, more particularly, to apparatus and methods for straightening the bends of angled tissue cutting instruments.[0003]
2. Brief Discussion of the Related Art[0004]
Tissue cutting instruments comprising an elongate outer tubular member and an elongate inner member rotatably disposed in the outer tubular member to cut anatomical tissue have become well accepted for use in various surgical procedures. Typically, the inner member has a distal end with a cutting edge and the outer member has an opening through which the cutting edge is exposed to access anatomical tissue to be cut by the cutting edge when the inner member is rotated within the outer member. The cutting edge may have various configurations in accordance with the type of tissue and/or the type of cutting action to be accomplished. In some instances, the distal end of the outer member has a cutting edge cooperable with the cutting edge of the inner member to cut the anatomical tissue as the inner member is rotated. The outer and inner members ordinarily have proximal ends adapted for coupling with a powered surgical handpiece used to rotate the inner member relative to and within the outer member. Many tissue cutting instruments provide for aspiration of anatomical debris through the tissue cutting instrument and/or irrigation at the operative site via an irrigating or flushing fluid supplied along the tissue cutting instrument.[0005]
In tissue cutting instruments of the foregoing type, the outer members may be longitudinally or axially straight or may be longitudinally or axially bent, angled or curved depending on the surgical procedure being performed. Where the outer member is longitudinally or axially bent, angled or curved, the inner member is normally provided with a flexible region adjacent or within the bend, angle or curve in the outer member whereby the inner member assumes the longitudinally or axially bent, angled or curved configuration of the outer member while still being rotatable within the outer member. Angled tissue cutting instruments of the latter type are represented by U.S. Pat. No. 177,490 to Fones, U.S. Pat. No. 4,445,509 to Auth, U.S. Pat. No. 4,466,429 to Loscher, U.S. Pat. No. 4,646,738 to Trott, U.S. Pat. No. 5,152,744 and U.S. Pat. No. 5,322,505 to Krause et al, U.S. Pat. No. 5,286,253, U.S. Pat. No. 5,411,514 and U.S. Pat. No. 5,601,586 to Fucci et al, U.S. Pat. No. 5,437,630 to Daniel et al, U.S. Pat. No. 5,529,580 to Kusumoki et al, U.S. Pat. No. 5,620,415 to Lucy et al, U.S. Pat. No. 5,620,447 to Smith et al and U.S. Pat. No. 5,922,003 to Anctil et al.[0006]
In most angled tissue cutting instruments, the bend, curve or angle is pre-formed in the outer member as part of the manufacturing or fabrication process and is essentially rigid or fixed. However, U.S. Pat. No. 5,601,586 and No. 5,411,514 to Fucci et al are representative of variable angle tissue cutting instruments in which a longitudinally straight outer member has a spiral relief cut forming a non-rigid bendable section along which the outer member may be bent axially by a user, and the inner member is flexible to follow the bent configuration of the outer member. Accordingly, the Fucci et al patents are representative of angled tissue cutting instruments in which the bend is pre-formed in the outer member subsequent to the manufacturing process and is essentially non-rigid or variable. The Fucci et al patents also disclose bending tools permitting a user to bend the longitudinally straight outer member axially along the non-rigid bendable section to assume various predetermined angles.[0007]
The bending tools disclosed in the Fucci et al patents operate by bending a longitudinally straight outer tube into contact with an angled limit surface disposed at a greater angle than the bend angle to be created in the outer tube and then allowing the outer tube to spring back in a direction away from the limit surface to obtain the bend angle. The angles of the limit surfaces specifically provide for a spring back to create a significant positive bend angle in the outer tube, and the bending tools are not designed with limit surfaces capable of providing a spring back for unbending or straightening an already bent or angled outer tube to obtain a longitudinally straightened outer tube.[0008]
Angled tissue cutting instruments in which the outer members are pre-formed with an essentially fixed bend, angle or curve may advantageously be precision manufactured with the bend, angle or curve formed with exactitude to extend in a pre-selected direction at a specified location and angle with a predetermined radius of curvature. Accordingly, the outer member can be manufactured with a pre-formed angle, bend or curve that is optimal for the surgical procedure being performed. As an example, the outer member can have a pre-formed bend, curve or angle that is optimal for use of the instrument as an adenoid blade. In many surgical procedures facilitated by an angled tissue cutting instrument, it is preferable that the outer member be pre-formed with the most desirable or advantageous bend, curve or angle for the particular surgical procedure to ensure that the most optimal outer member configuration is used for the particular surgical procedure.[0009]
In some surgical procedures, it is desirable to utilize angled tissue cutting instruments to remove anatomical tissue and to thereafter utilize longitudinally or axially straight tissue cutting instruments for further removal of anatomical tissue. In a combined tonsillectomy and adenoidectomy (T&A) procedure, for instance, an adenoidectomy is performed prior to a tonsillectomy to remove all or part of an adenoid using an angled tissue cutting instrument as represented by the adenoid blade disclosed in the aforementioned Anctil et al patent and by the RADenoid® Blade of Medtronic Xomed Surgical Products, Inc. The tonsillectomy is thereafter performed, typically utilizing the same angled tissue cutting instrument or another different tissue cutting instrument in which the outer member is longitudinally or axially straight. Performing the tonsillectomy using the angled tissue cutting instrument that was used for the adenoidectomy, i.e. the adenoid blade, is disadvantageous since longitudinally or axially straight tissue cutting instruments provide better access to the tonsils. Using another different tissue cutting instrument having a longitudinally or axially straight outer member for the tonsillectomy is also disadvantageous for the increased cost associated with an additional instrument and/or the additional surgical time associated with preparing the additional instrument for use. The added steps involved in preparing an additional instrument for use during surgery may include removing the instrument from its package, assembling the inner member of the instrument within the outer member, coupling the inner member and the outer member to the surgical handpiece, and/or removing the angled tissue cutting instrument from the surgical handpiece so that the same handpiece can be coupled with the inner and outer members of the additional instrument. Furthermore, the need to inventory and supply both angled and straight tissue cutting instruments for a surgical procedure imposes a difficult burden on hospitals and other surgical sites.[0010]
In various sinus procedures, it is also common for surgeons to initially utilize an angled tissue cutting instrument to remove anatomical tissue and to thereafter utilize a straight tissue cutting instrument to further remove anatomical tissue. The Rad® 40 Curved Blade and the[0011]Rad 60 X-TREME™ Curved Blade of Medtronic Xomed Surgical Products are representative of angled tissue cutting instruments which allow access into the frontal recess and maxillary sinus and are popular for use in sinus surgery, particularly superior ethmoid and frontal recess surgery, removal of maxillary polyps, uncinectomy and antrostomy. During sinus surgery where tissue removal is initially effected using an angled tissue cutting instrument, the surgeon will sometimes switch to a longitudinally straight tissue cutting instrument where needed to afford better access for further tissue removal. As discussed above, the need to switch between two different instruments during a surgical procedure presents numerous drawbacks.
Sometimes angled tissue cutting instruments having blades with a particular distal end cutting configuration are available to surgeons without there being available straight tissue cutting instruments having the particular distal end cutting configuration. There arises an unsatisfied need where a surgeon desires to use the particular distal end cutting configuration of an available angled tissue cutting instrument but as a longitudinally straight tissue cutting instrument. Accordingly, an angled tissue cutting instrument may have to be used in a surgical procedure in which use of a counterpart straight tissue cutting instrument would be more preferable.[0012]
Where an angled tissue cutting instrument is to be used in a surgical procedure alone or prior to using a longitudinally straight tissue cutting instrument, the need to bend an initially straight outer tube to obtain the angled tissue cutting instrument as required by the Fucci et al patents is undesirable for the additional time and procedural steps added to the surgical procedure. An angled tissue cutting instrument having a bent outer tube obtained using the bending tools of the Fucci et al patents cannot thereafter be reliably straightened for use as a longitudinally straight tissue cutting instrument since the bending tools are incapable of reversely bending a previously bent outer tube with any degree of precision or control to obtain a longitudinally straight outer tube.[0013]
It is seen from the above that a need exists for apparatus and methods to effect controlled unbending or straightening of an angled, bent or curved member of an angled tissue cutting instrument to obtain a longitudinally or axially straight tissue cutting instrument therefrom. Apparatus and methods are needed which are capable of accomplishing unbending or straightening of an angled tissue cutting instrument prior to or during a surgical procedure in a brief amount of time using a minimal number of simple procedural steps. In particular, apparatus and methods are needed for unbending or straightening an angled tissue cutting instrument for use as a longitudinally straight tissue cutting instrument during a surgical procedure to ensure that the instrument has both the optimal distal end cutting configuration and the optimal longitudinal profile for the surgical procedure and/or to eliminate the need for surgeons to switch between different instruments during the surgical procedure. There is also a need to reduce the number of different instruments required to be made available for and/or used during a surgical procedure to reduce surgical costs and the burden on hospitals and other surgical sites associated with maintaining and supplying many different instruments. Especially in the areas of T&A procedures and sinus procedures, the need exists for allowing a pre-formed angled tissue cutting instrument to be used in a surgical procedure to remove anatomical tissue and to be thereafter straightened or unbent for further use in the surgical procedure to remove anatomical tissue as a longitudinally straight tissue cutting instrument. There is also a need to permit an available angled tissue cutting instrument having a particular distal end cutting configuration desirable for use in a surgical procedure to be straightened or unbent prior to the surgical procedure to assume a straight longitudinal profile that is more preferable for the surgical procedure than an angled longitudinal profile. There is a further need for an unbending or straightening tool having a contact surface against which an angled member of an angled tissue cutting instrument is reversely bent and then allowed to spring back in a direction away from the contact surface to obtain a longitudinally straight member. An unbending or straightening tool for angled tissue cutting instruments is needed having a contact surface at the proper angle to controllably unbend the angled members of the angled tissue cutting instruments to obtain longitudinally straight members after accounting for spring-back of the members. An additional need prevails for an unbending or straightening tool having a guide template allowing a particular angled member to be matched with the guide template for unbending using an unbending channel of the tool corresponding to the guide template. A still further need exists for an unbending tool having a plurality of unbending channels for angled members of different longitudinal profiles, respectively, and a guide template for each unbending channel to facilitate matching the different angled members with the appropriate unbending channels.[0014]
SUMMARY OF THE INVENTIONAccordingly, it is a primary object of the present invention to overcome the aforementioned disadvantages of the prior art.[0015]
Another object of the present invention is to match a pre-bent adenoid blade to a guide template of a straightening tool, to straighten the adenoid blade using an unbending channel of the straightening tool corresponding to the guide template subsequent to performing an adenoidectomy with the adenoid blade, and to thereafter perform a tonsillectomy with the straightened blade.[0016]
A further object of the present invention is to eliminate the need for hospitals and other surgical sites to supply both angled and straight tissue cutting instruments for T&A, sinus, laryngeal and other surgical procedures.[0017]
The present invention also has as an object to ensure the use of the most optimal distal end cutting configurations and/or longitudinal profiles for a blade used throughout a surgical procedure such as T&A, sinus, laryngeal and other surgical procedures.[0018]
An additional object of the present invention is to straighten an angled tissue cutting instrument used during a surgical procedure for subsequent use during the surgical procedure as a longitudinally straight tissue cutting instrument, and to accomplish the straightening using a straightening tool having an unbending channel matched to the longitudinal profile of a forward aspect of the instrument.[0019]
Still a further object of the present invention is to straighten an available angled tissue cutting instrument prior to a surgical procedure to obtain a straight tissue cutting instrument that is more preferable for use in the surgical procedure than the angled instrument, and to accomplish the straightening using a straightening tool having a guide slot complementary to the longitudinal profile of a forward aspect of the instrument prior to straightening.[0020]
It is also an object of the present invention to utilize one tissue cutting instrument in a surgical procedure normally requiring a plurality of different tissue cutting instruments.[0021]
The present invention has as another object to reduce the cost of surgery by reducing the number of different tissue cutting instruments required to perform a surgical procedure.[0022]
Yet a further object of the present invention is to reduce the time needed to perform a surgical procedure by eliminating the need to switch between different tissue cutting instruments during the surgical procedure.[0023]
Moreover, it is an object of the present invention to provide a straightening tool of simplified construction and operation for straightening an angled tissue cutting instrument.[0024]
The present invention also has as an object to straighten an angled tissue cutting instrument in a short amount of time using a minimal number of procedural steps.[0025]
Still another object of the present invention is to controllably reverse bend an angled member of a tissue cutting instrument to obtain a longitudinally straight member after spring-back of the member.[0026]
The present invention has as an additional object to ensure use of an optimal unbending channel of a straightening tool to straighten an angled member of a tissue cutting instrument.[0027]
An additional object of the present invention is to provide a straightening tool with a guide template for matching with the longitudinal profile of a forward aspect of an angled member to be straightened using an unbending channel of the tool corresponding to the guide template.[0028]
Yet another object of the present invention is to ensure proper positioning of a forward aspect of an angled member of an angled tissue cutting instrument in an unbending channel of a straightening tool by inserting the forward aspect in the unbending channel through a guide template of the tool.[0029]
It is a further object of the present invention to provide a plurality of unbending channels in an unbending tool for a plurality of different angled tissue cutting instruments, with the unbending channels optimally corresponding to different longitudinal profiles for the angled tissue cutting instruments, respectively, prior to unbending thereof.[0030]
The present invention also has as an object the provision of a guide template for each of a plurality of unbending channels of an unbending tool for a plurality of different angled tissue cutting instruments by which the instruments are reliably matched to the appropriate unbending channels therefor.[0031]
Some of the advantages of the present invention are that the angled outer members of angled tissue cutting instruments are straightened without kinking; the angled outer members of the angled tissue cutting instruments are straightened while retaining their structural integrity; the proximal ends of the outer members are not bent out of alignment with the powered surgical handpieces as a consequence of unbending; the inner members can remain disposed within the outer members as the outer members are straightened or can be removed from the outer members prior to the outer members being straightened; the outer and inner members can remain coupled to the powered surgical handpieces as the outer members are straightened with the inner members disposed therein; the outer members are straightened without damage to the cutting edges and/or openings at their distal ends; where the outer members are straightened with the inner members disposed therein, the cutting edges and/or openings of the inner members are not damaged; straightening of an angled member may be accomplished by one person using a simple process; a single straightening tool can be used to straighten various angled tissue cutting instruments having bends of various angles and radii of curvature at various locations and/or having various working lengths and/or outer diameters; the straightening tools can be designed to straighten angled tissue cutting instruments of different types and/or manufacturers; the straightening tools are capable of being sterilized to medical standards to maintain the sterility of the angled tissue cutting instruments being straightened; the simplified construction of the straightening tools promotes sterilization; the straightening tools may be reusable for repeated use or may be disposable for single patient use; and the guide templates of the straightening tools match the actual longitudinal profiles of the angled members prior to straightening and thereby allow actual comparison or matching.[0032]
These and other objects, advantages and benefits are realized with the present invention as generally characterized in a straightening tool for straightening an elongate angled member of an angled tissue cutting instrument in which the elongate angled member has a proximal length portion and an initial bend connecting the proximal length portion to a distal length portion extending from the bend to a distal end. The straightening tool comprises a positioning block attached to a handle, an unbending channel in the positioning block and a guide template corresponding to the unbending channel. The unbending channel is configured to effect straightening of the elongate angled member. The guide template comprises a guide slot disposed along an external wall of the positioning block and having a longitudinal profile corresponding to the longitudinal profile of a forward aspect of the elongate angled member. In one embodiment, the guide template includes a first length section corresponding to part of the proximal length portion of the elongate angled member extending from the initial bend, an angled length section corresponding to the initial bend of the elongate angled member and a second length section corresponding to the distal length portion of the elongate angled member. Where the proximal and distal length portions of the elongate angled member are straight, the first and second length sections of the guide template are correspondingly straight with the angled length segment being bent, curved or angled to correspond to the initial bend of the elongate angled member. The longitudinal profile of the elongate angled member to which the longitudinal profile of the guide template corresponds includes the bend, curve or angle, the working length and the outer diameter of the angled member along the forward aspect. The guide slot is thusly configured and sized to receive the longitudinal profile of the forward aspect of the elongate angled member with a complementary or close fit, and the guide slot may be in communication with the unbending channel to allow the forward aspect to be moved along the guide slot and into the unbending channel. The guide template relates or corresponds to the unbending channel and, by matching the angled member to the guide template, the angled member is matched to the most optimal unbending channel to effect straightening of the angled member. The unbending channel may have an upper surface conforming to the longitudinal profile of the angled member along its forward aspect and to the upper surface of the guide template. The unbending channel comprises a confinement passage for confining the distal length portion of the elongate angled member against movement in a direction radial or transverse to a longitudinal axis of the distal length portion while permitting pivotal movement of the proximal length portion in a direction opposite the initial bend and relative to the distal length portion confined in the confinement passage. The unbending channel may have a contact surface against which the proximal length portion is reversely bent, and the contact surface is angled from the confinement passage at an angle to obtain straightening of the angled member after spring back in the direction of the initial bend. The straightening tool may comprise a plurality of unbending channels configured to effect straightening of a plurality of elongate angled members having different longitudinal profiles along their forward aspects and a plurality of corresponding guide templates matching the longitudinal profiles of the forward aspects of the different elongate angled members, respectively. The straightening tool may comprise a single positioning block having a plurality of unbending channels and guide templates corresponding thereto. The straightening tool may comprise a plurality of positioning blocks, each having one or more unbending channels and corresponding guide templates.[0033]
The present invention is also generally characterized in a method of straightening an elongate angled member of an angled tissue cutting instrument in which the elongate angled member has a proximal length portion and an initial bend connecting the proximal length portion to a distal length portion extending from the bend to a distal end. The method involves the steps of matching the longitudinal profile of a forward aspect of the elongate angled member to a guide template of a straightening tool, inserting the forward aspect into an unbending channel of the straightening tool corresponding to the guide template that was matched to the elongate angled member, confining the distal length portion in a confinement passage of the unbending channel to confine the distal length portion against movement in a direction radial or transverse to a longitudinal axis of the distal length portion, applying force to the elongate angled member to forcefully pivot the proximal length portion in a direction opposite the initial bend and relative to the distal length portion confined in the confinement passage, releasing the force applied to the elongate member to allow the proximal length portion to spring back in the direction of the initial bend to obtain a straight elongate member, and withdrawing the straight elongate member from the unbending channel. The longitudinal profile of the forward aspect that is matched to the guide template may include the distal length portion, the initial bend and part of the proximal length portion extending from the initial bend. The longitudinal profile of the forward aspect may be visually matched to the guide template via a side-by-side comparison and/or may be inserted in the guide template with a complementary fit. Insertion of the forward aspect into the unbending channel may be accomplished by moving the forward aspect within and along the guide template into the unbending channel in communication with the guide template. The proximal length portion may be forcefully pivoted manually, and the proximal length portion may be pivoted into contact with a contact surface of the straightening tool disposed at an angle to the confinement passage such that a reverse positive bend is imparted to the elongate member opposite the initial bend prior to the elongate member springing back in the direction of the initial bend. The step of matching may involve matching the longitudinal profile of the forward aspect of the elongate angled member to one of a plurality of different guide templates of the straightening tool corresponding to a plurality of different unbending channels of the straightening tool, respectively, and the step of inserting may include inserting the forward aspect into the unbending channel which corresponds to the matching guide template.[0034]
BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1 is a side view of an angled tissue cutting instrument or blade.[0035]
FIG. 2 is an exploded side view, partly in section, of the angled tissue cutting instrument.[0036]
FIG. 3 is a broken perspective view depicting the forward aspect of an elongate angled member of the angled tissue cutting instrument of FIG. 1 matched to a guide template of a straightening or unbending tool.[0037]
FIG. 4 is a broken top view of the straightening tool.[0038]
FIG. 5 is an end view of the straightening tool.[0039]
FIG. 6 is a broken longitudinal sectional view of the straightening tool illustrating straightening of the angled member using an unbending channel of the straightening tool corresponding to the matching guide template.[0040]
FIG. 7 is a broken perspective view illustrating an alternative straightening tool according to the present invention having a plurality of different guide templates corresponding to a plurality of different unbending channels, respectively, for a plurality of different elongate angled members, respectively, of angled tissue cutting instruments.[0041]
FIG. 8 is a broken perspective view showing the alternative straightening tool and the plurality of different elongate angled members rotated 180°.[0042]
FIG. 9 is a top view of the alternative straightening tool.[0043]
FIG. 10 is an end view of the alternative straightening tool.[0044]
FIG. 11 is an opposite end view of the alternative straightening tool.[0045]
FIG. 12 depicts an adenoidectomy performed using the angled tissue cutting instrument of FIG. 1 in a T&A procedure.[0046]
FIG. 13 shows a straight tissue cutting instrument obtained by matching the angled tissue cuffing instrument of FIG. 1 to the guide template of the straightening tool of FIG. 3 and straightening the angled tissue cuffing instrument using the unbending channel of the straightening tool corresponding to the matching guide template subsequent to the adenoidectomy, and depicts use of the straight instrument to perform a tonsillectomy in the T&A procedure.[0047]
FIG. 14 is a broken perspective view of an alternative angled tissue cutting instrument or blade.[0048]
FIG. 15 depicts removal of sinus tissue using the angled tissue cutting instrument of FIG. 14 during a sinus procedure.[0049]
FIG. 16 shows a straight tissue cutting instrument obtained by matching the angled tissue cutting instrument of FIG. 14 to the matching guide template of the alternative straightening tool of FIG. 7 and straightening the angled tissue cutting instrument using the unbending channel of the alternative straightening tool corresponding to the matching guide template subsequent to removal of sinus tissue therewith, and depicts use of the straight instrument to further remove sinus tissue during the sinus procedure.[0050]
DESCRIPTION OF THE PREFERRED EMBODIMENTSThe present invention relates to a straightening or unbending tool or apparatus for straightening or unbending an elongate angled member of an angled tissue cutting instrument and, in particular, the angled outer member of an angled tissue cutting instrument. As used herein, the terms “forward”, “rearward”, “inferiorly,” “bottom,” “downward,” “superiorly,” “top,” “upward,” “lateral,” “side” and their derivatives are all relative terms that may vary depending on the orientations of the tools and the angled members and should not be construed as limitations to the features described thereby. The terms “angled”, “bent” and “curved” and their derivatives are used synonymously, and the terms “straightening” and “unbending” and their derivatives are also used synonymously.[0051]
An angled tissue cutting instrument or[0052]blade10 is illustrated in FIGS. 1 and 2 and includes an elongate angled outertubular member12 and an elongateinner member14 rotatably or movably disposed within the outer member.Outer member12, which may be considered an outer blade member, comprises a proximal end coupled to anouter member hub16, aproximal length portion18 of longitudinally or axially straight configuration extending distally from the outer member hub to an initial bend, curve orangle20, and adistal length portion22 extending distally frombend20 todistal end26. Thedistal length portion22 is oriented at an angle A relative to the centrallongitudinal axis24 of the proximal length portion and is of longitudinally or axially straight configuration extending distally frombend20. Theouter member12 has anopening28 therein adjacentdistal end26. The angle A is defined between a centrallongitudinal axis30 of the distal length portion and the centrallongitudinal axis24. The length of thedistal length portion22 frombend20 to thedistal end26 may be considered as defining the working length ofblade10 andouter member12. A forward aspect of theouter member12 comprisesdistal length portion22,bend20, and at least part of theproximal length portion18 extending frombend20. Theouter member12 has a longitudinal profile along its forward aspect including angle A, the working length and the outer diameter of the outer member along the forward aspect.
The[0053]outer member12 may comprise a rigid member formed by bending a continuous and unbroken tubular member of solid wall construction and uniform wall thickness, such that theinitial bend20 may be pre-formed therein as part of the fabrication or manufacturing process. Although the bentouter member12 is essentially rigid, it is capable of being reverse bent to removebend20 therefrom when sufficient force is applied thereto. The orientation of opening28, the angle, radius of curvature and location ofbend20, the working length, and the outer diameter of the outer member are dependent on the surgical procedure to be performed. The angledtissue cutting instrument10 is particularly designed for use as an adenoid blade with thedistal length portion22 extending frombend20 at an angle A of about 40 degrees relative to the centrallongitudinal axis24, thebend20 having a radius of curvature R of about 0.875 inch and a location about 0.7 inch from the distal end, and theopening28 facing outwardly relative to the direction of the bend, i.e. relative to the center of curvature for the bend. Theouter member12 is typically made of a medically acceptable metal such as stainless steel.
[0054]Outer members12 may be made available having different bend angles A, working lengths and/or outer diameters. Representative outer members having illustrative combinations of angles and outer diameters include an outer member having an angle A of 45° and an outer diameter of 4.5 mm, an outer member having an angle A of 60° and an outer diameter of 3.5 mm, an outer member having an angle A of 12° and an outer diameter of 4.0 mm, and an outer member having an angle A of 40° and an outer diameter of 4.0 mm. The representative outer members can have any suitable working lengths.
[0055]Inner member14, which may be considered an inner blade member, may be tubular or non-tubular but is shown as being tubular in the case ofinstrument10.Inner member14 has aproximal length region32 extending distally from aninner member hub34, a distal end formed as or provided with a cutting tip36 and a flexible orbendable region38 betweenproximal length region32 and cutting tip36. The cutting tip36 is adapted to cut anatomical tissue, and the cutting tip forinner member14 includes anopening40 communicating with alumen42 through the inner member and acutting edge44 along a peripheral edge ofopening40. The cuffingedge44 may be designed in various ways, for example as a sharp peripheral edge of opening40 or as a plurality of cutting teeth along a peripheral edge of theopening40 as shown forinner member14. When theinner member14 is disposed within theouter member12 as shown in FIG. 1, the inner member extends through theouter member hub16 with theinner member hub34 disposed proximally of the outer member hub, thecutting edge44 is exposed by theopening28 ofouter member12, and theflexible region38 is disposed within or adjacent thebend20 so that the inner member follows or conforms to the longitudinally or axially bent, curved or angled configuration of the outer member. Theproximal length region32 is rigid and transmits torque from a powered surgical handpiece, shown at84 in FIG. 6, via theflexible region38 to rotate the cutting tip36 when theinner member14 is rotated relative to and within theouter member12 by the powered surgical handpiece. Theflexible region38 allows theinner member14 to conform to the angled configuration of theouter member12 as it is rotated relative to and within the outer member. Thehubs16 and34 are adapted to be removably coupled with the powered surgical handpiece, and the powered surgical handpiece may be of the type disclosed in U.S. Pat. No. 5,916,231 to Bays, the entire disclosure of which is incorporated herein by reference. Depending on the design of the angled tissue cutting instrument, the inner member may or may not be removable from the outer member.
The cutting tip[0056]36 can have various configurations depending on the surgical procedure to be performed. The cutting tip36 accesses anatomical tissue at an operative site via theopening28 ofouter member12 and is aligned with or disposed adjacent theopening28 as theinner member14 is rotated with in theouter member12. Theouter member12 can be provided with or without a cutting edge. In the case ofinstrument10, theouter member12 is shown as having a cuttingedge46 cooperable with thecutting edge44 ofinner member14 to cut anatomical tissue as the inner member is rotated within the outer member. Thecutting edge46 may likewise be designed in various ways, for example as a sharp peripheral edge of opening28 or as a plurality of cutting teeth along a peripheral edge of theopening28 as shown in FIGS. 1 and 2. Thecutting edge44 moves past thecutting edge46 as the inner member is rotated within the outer member to cut anatomical tissue. Anatomical debris may be aspirated from the operative site through thelumen42 ofinner member14, theopening40 of the inner member forming a suction inlet through which debris is aspirated. Where the powered surgical handpiece of the aforementioned Bays patent is used, the debris is aspirated through the inner member and the handpiece. The flexible region of the inner member can be formed in various ways, theflexible region38 being formed by way of example of a reinforced polymeric material. Theinner member14 is made of a medically acceptable or biocompatible material such as stainless steel. For use as an adenoid blade, the angledtissue cutting instrument10 may be a RADenoide Blade of Medtronic Xomed Surgical Products, as represented by U.S. Pat. No. 5,922,003 to Anctil et al, the entire disclosure of which is incorporated herein by reference. As described further below, the angled tissue cutting instrument may be a sinus blade such as theRAD® 40 Curved Blade or theRAD 60 X-TREME™ Curved Blade of Medtronic Xomed Surgical Products.
Aspiration may be accomplished in the angled[0057]tissue cutting instrument10 through the inner member, through the outer member, such as between the outer member and the inner member, or in any other suitable manner. However, it should be appreciated that the angled tissue cutting instrument can be provided and/or used without aspiration. The angled tissue cutting instrument may be provided with or without an irrigation passage or channel for supplying irrigating or flushing fluid to the operative or cutting site and both aspiration and irrigation may be provided in the angled tissue cutting instrument. Irrigation may be provided along the instrument in various ways including through the inner member, through the outer member, such as between the outer member and the inner member, externally along the outer member, or in any other suitable manner. In theinstrument10, for example, theouter member hub16 has anoptional nipple48 extending proximally from a side of the outer member hub at an acute angle relative to the centrallongitudinal axis24 and communicating with an annular space between theouter member12 and theinner member14. When a source of irrigating or flushing fluid is connected with thenipple48, the fluid will be supplied to the operative or cuffing site via theopening28, for example to irrigate the site or clear blockages. The angled tissue cutting instrument may include an external irrigation channel as disclosed in U.S. Pat. No. 5,782,795 to Bays and No. 6,312,438 B1 to Adams, the entire disclosures of which are incorporated herein by reference. The Adams patent is also representative of a burr tip which may be used as the cutting tip in the angled tissue cutting instrument and of an aspiration passage and aspiration ports which may be incorporated in the inner member.
Although the straightening tool of the present invention is particularly desirable for use with a curved, bent or angled adenoid blade, as represented by the angled[0058]tissue cutting instrument10 and by the RADenoid® Blade of Medtronic Xomed Surgical Products, and with a curved, bent or angled sinus blade as represented by theRAD 40® Curved Blade andRAD 60 X-TREME® Curved Blade of Medtronic Xomed Surgical Products, it should be appreciated that the straightening tool can be used or adapted for use with various other types of curved, bent or angled tissue cutting instruments of various manufacturers. In particular, the straightening tool can be adapted for use with laryngeal blades, as represented by the Skimmer Angle-Tip blades and the Tricut™ Angle-Tip blades of Medtronic Xomed Surgical Products, used by way of example for supraglottic and subglottic papilldma removal or debulking, tumor debulking, tracheal stenosis and trans-sphenoidal hypophysectomy.
A straightening or unbending tool or[0059]apparatus50 according to the present invention is illustrated in FIGS. 3-6 and includes an unbending channel for unbending an elongate angled member, such as angledouter member12, having a particular longitudinal profile along its forward aspect and a guide template for matching the angled member to the unbending channel. The straighteningtool50 is integrally, unitarily or monolithically formed as one piece with no moving parts and includes ahandle52 and apositioning block54 extending from the handle. Thehandle52 comprises an elongatecylindrical section56 joined at one end thereof to a partialspherical cap58 and joined at the opposite end thereof to positioningblock54. Thecylindrical section56 may be provided with external ridges or grooves, as shown in FIG. 3, to accommodate the fingers of a hand grasping thehandle52, and/or the handle may have various ergodynamic external configurations.
The[0060]positioning block54 hasexternal side walls55aand55bextending fromhandle52 to an externalforward end wall62 and has external top andbottom walls57aand57bextending fromhandle52 to endwall62. Theside walls55aand55bmay be planar and parallel to one another, and may be tangential to the circumference ofcylindrical section56 as shown for positioningblock54. Theend wall62 may be perpendicular to theexternal side walls55aand55b. The top andbottom walls57aand57bmay each comprise a first or rearwardtop wall segment59 extending angularly outwardly from thehandle52 to a second or forwardtop wall segment61 extending from the firsttop wall segment59 to endwall62. The firsttop wall segments59 may extend angularly outwardly in opposite directions to each other, and the secondtop wall segments61 may be parallel to one another. The first and secondtop wall segments59 and61 may be outwardly curved or convex betweenside walls55aand55bas best shown in FIG. 5. Preferably, thepositioning block54 has blunt, rounded or smooth corners and edges. Thepositioning block54 can have various external configurations other than the configuration shown in FIGS. 3-6 with anunbending channel64 disposed within the positioning block and aguide template66 disposed along an external wall of the positioning block.
The[0061]unbending channel64 comprises aconfinement passage68 and anunbending slot70 extending from the confinement passage to an open end alongend wall62. Theconfinement passage68 is bounded rearwardly by internal rearward orabutment wall72, inferiorly byinternal bottom wall74 and superiorly by internaltop wall76. One side of theconfinement passage68 bounded laterally byinternal side wall78aextending between the bottom andtop walls74 and76, while the opposite side of the confinement passage is open to theguide template66. Thebottom wall74, which is planar, extends forwardly fromabutment wall72 to acontact surface80 extending downwardly at an angle frombottom wall74 to endwall62. Thetop wall76 extends forwardly from theabutment wall72 to an internalupper wall82 of theunbending slot70, and thetop wall76 is planar and parallel to thebottom wall74. The distance between the bottom andtop walls74 and76 defines a confinement passage dimension selected to accommodate, with a close fit, the outer diameter of thedistal length portion22 of theangled member12 to be straightened using theunbending channel64 oftool50 as described further below. Theconfinement passage68 may be coaxial withhandle52 as shown fortool50 or may be non-coaxial therewith as shown fortool150.
The[0062]unbending slot70 extends from theconfinement passage68 to the open end thereof alongend wall62. Theunbending slot70 is bounded laterally by opposinginternal side walls78aand78b, inferiorly bycontact surface80 and superiorly byupper wall82. Theside wall78aextends fromabutment wall72 to endwall62 while theside wall78bextends from theconfinement passage68 to endwall62. Theside walls78aand78bare planar and parallel to one another. Thecontact surface80 extends between theside walls78aand78b. Theupper wall82 comprises a curved or angled upper wall segment extending from thetop wall76 to a straight upper wall segment ofupper wall82 extending from the curved or angled upper wall segment to the open end of theunbending slot70. Thecontact surface80 is preferably curved between theside walls78aand78bto cradle the outer diameter of theangled member12 during straightening or unbending thereof. The distance between theinternal side walls78aand78bdefines an unbending slot dimension selected to accommodate the outer diameter of theangled member12 with a close fit while still allowing theproximal length portion18 to be pivotally moved in theunbending slot70 to effect straightening as explained below. In the case oftool50, theunbending slot70 andconfinement passage68 are bisected by a plane parallel tointernal side walls78aand78band containing the central longitudinal axis of theconfinement passage68. The open end of unbendingslot70 extends alongend wall62 fromcontact surface80 to theupper wall82. In the case oftool50, theupper wall82 and the open end ofslot70 terminate along externaltop wall57aso that the open end ofslot70 extends fromend wall62 some distance longitudinally along externaltop wall57a. The length of the open end ofslot70 may vary in accordance with the angle of the angled member to be straightened by unbendingchannel64 and the angle required forcontact surface80. Depending on the angle of the angled member, the open end ofslot70 need not extend along the external top wall and may be confined to endwall62 as described and illustrated forunbending tool150.
The[0063]guide template66 comprises a guide slot or track having a longitudinally extending opening alongexternal side wall55band communicating with theunbending channel64. Theguide template66 extends from theexternal side wall55bto theunbending channel64 in a direction transverse to the plane of theunbending channel64. The longitudinal profile ofguide template66 corresponds to the longitudinal profile of the forward aspect ofangled member12, and the longitudinal profile of the guide template may be of uniform cross-section betweenexternal wall55bandunbending channel64. As best shown in FIG. 3, the longitudinal profile of theguide template66 includes a first orforward length section86 corresponding to part of theproximal length portion18 ofouter member12 extending frombend20, a second orrearward length section88 corresponding to thedistal length portion22 ofouter member12 and a bent, curved orangled length section90 joining the first andsecond length sections86 and88. Theangled length section90 corresponds to the initial curve, bend orangle20 ofouter member12. Theguide template66 terminates at one end atabutment wall72, which extends in the transverse direction from theexternal side wall55bto theinternal side wall78aand defines a closed end for the guide template. Theguide template66 terminates at an opposite end at a transverse opening extending from theexternal side wall55bto theinternal side wall78b, such that the transverse opening is in communication with theunbending slot70.
The[0064]second length section88 of theguide template66 is bounded inferiorly bybottom wall74 and superiorly by thetop wall76, the bottom andtop walls74 and76 extending in the transverse direction frominternal side wall78ato theexternal side wall55b. Thefirst length section86 and theangled length section90 of theguide template66 are bounded inferiorly by an internallower wall92, shown in FIG. 3, extending in the lateral or transverse direction frominternal side wall78btoexternal side wall55band are bounded superiorly byupper wall82 which extends in the transverse direction frominternal side wall78atoexternal side wall55b. Thelower wall92 is parallel toupper wall82. The central longitudinal axis of thesecond length section88 ofguide template66 is disposed at angle A to the central longitudinal axis of thefirst length section86 thereof such that theangled length section90 has a bend angle that is the same as the bend angle A of theouter member12. Theguide template66 has an upper surface comprising internaltop wall76 and internalupper wall82, and a lower surface comprising internalbottom wall74 and internallower wall92. The upper surface of the guide template is parallel to the lower surface thereof, with the distance between the upper and lower surfaces of the guide template defining a uniform cross-sectional dimension for the guide template fromexternal side wall55bto theunbending channel64. The uniform cross-sectional dimension of theguide template66 closely corresponds to the longitudinal profile of the forward aspect ofangled member12, allowing the forward aspect of theouter member12 to be positioned in the guide template via the opening of the guide template alongexternal side wall55bas represented in FIG. 3. It is preferred that the cross-sectional dimension of the guide template match or correspond as close as possible to the longitudinal profile of theangled member12 along its forward aspect to allow a complementary, mating or close fit between the forward aspect and the guide template, while still allowing the forward aspect to be moved transversely within and along the guide template into theunbending channel64 as described further below. The upper surface of theguide template66 conforms to or follows the same longitudinal configuration or profile as the upper or confirming surface of theunbending channel64 defined by thetop wall76 ofconfinement passage68 andupper wall82 of unbendingslot70.
The[0065]second length section88 of theguide template66 matches or corresponds in longitudinal profile to thedistal length portion22 ofangled member12, and theangled length section90 of the guide template has a bend, curve or angle that matches or corresponds in longitudinal profile to theinitial bend20 of theangled member12. Thefirst length section86 of the guide template matches or corresponds in longitudinal profile to at least part of theproximal length portion18 ofangled member12 extending frombend20. Accordingly, the longitudinal profile of theguide template66 matches or corresponds to and is complementary to the longitudinal profile of the forward aspect of theangled member12 including the angle A, the working length and the outer diameter of theangled member12 along its forward aspect. The longitudinal profile of theguide template66 is representative of the longitudinal profile of theunbending channel64 in that the upper surface of the unbending channel is continuous with and follows the longitudinal configuration or profile of the upper surface of the guide template while thebottom wall74 of theconfinement passage68 is continuous with and defines the longitudinal configuration or profile of the lower wall of the guide template along thesecond length section88. Accordingly, when thedistal length portion22 ofangled member12 is disposed in theconfinement passage68 withdistal end26 in abutment withabutment wall72, thedistal length portion22 is closely confined betweenwalls74 and76, thebend20 andproximal length portion18 extend closely along theupper wall82 of unbendingslot70, and theproximal length portion18 exits theunbending channel64 via the open end of the unbending slot. Theunbending channel64 is thusly optimally designed for the longitudinal profile ofangled member12 including the particular bend angle, working length and outer diameter forangled member12, with thecontact surface80 at the appropriate angle relative to theconfinement passage68 to effect straightening of the outer member after spring back as described further below. Theguide template66 corresponding to theunbending channel64 provides an external guide by which the angled member can be matched to the guide template and, therefore, to the unbending channel, so that the optimal unbending channel is used for unbending the angled member.
The[0066]contact surface80 is angled from thebottom wall74 ofconfinement passage68 in a direction opposite the angle ofupper wall82 of unbendingslot70, thecontact surface80 being angled downwardly in opposition to the upwardly angledupper wall82. Thecontact surface80 forms an angle with the plane ofbottom wall74 as described in the application incorporated herein by reference, and this angle is selected to obtain straightening ofangled member12 after spring back in the direction ofinitial bend20. The angle ofcontact surface80 may be in the range of 5 to 7 degrees.
The[0067]straightening tool50 is preferably made of a medically acceptable material, including metals, such as stainless steel, ULTEM, ABS, PEEK and LEXAN, for example, having sufficient strength to effect straightening or unbending of the angled member as explained further below. The straighteningtool50 may be fabricated by molding. The straighteningtool50 may be designed for sterilization to medical standards for repeated use or may be disposable after each use. The straighteningtool50 has no moving parts or inaccessible recesses such that proper sterilization is greatly facilitated. Various different straightening tools may be provided having various different unbending channels, respectively, and corresponding guide templates for various different angled members having forward aspects of various different longitudinal profiles. Alternatively, a single straightening tool may be provided with a plurality of various different unbending channels and guide templates corresponding thereto as explained below for straighteningtool150.
The[0068]guide template66 can be used to match the forward aspect of theangled member12 with theunbending channel64 so that the appropriate unbending tool or channel is selected for unbending theangled member12. Matching can be facilitated by placing the forward aspect of theangled member12 alongside theguide template66 with thedistal length portion22, thebend20 and theproximal length portion18 of the angled member aligned with thesecond length section88, theangled length section90 and thefirst length section86 of the guide template, respectively. Theangled member12 can also be introduced in theguide template66 with a complementary, close or mating fit via the longitudinal opening thereof alongexternal wall55bto confirm proper matching. When the forward aspect is introduced in the guide template, theproximal length portion18 of theangled member12 will extend externally from the transverse opening of theguide template66. Matching of the angled member to the appropriate unbending channel or tool may be performed prior to or during a surgical procedure in which the angledouter member12 is to be straightened for use as a longitudinally straight angled tissue cutting instrument, and matching may be performed just prior to straightening.
When it is desired to straighten or unbend[0069]angled member12 usingtool50 properly matched thereto, the angled member can be placed in theunbending channel64 by first placing the forward aspect of the angled member in theguide template66 via the opening alongexternal wall55band then moving the angled member along the guide template in the direction transverse to the plane of theunbending channel64, as permitted by the transverse opening of the guide template, to position the forward aspect in the unbending channel. Theguide template66 guides the forward aspect into theunbending channel64 so that thedistal end26 ofangled member12 abutsabutment wall72 with thedistal length portion22 confined inconfinement passage68, thebend20 disposed externally adjacent the confinement passage in unbendingslot70, and theproximal length portion18 extending closely alongupper wall82 to exit the unbending slot as shown in FIG. 6. By guiding the forward aspect of theangled member12 into theunbending channel64, theguide template66 ensures that the forward aspect is correctly positioned in the unbending channel. In addition, the forward aspect of theangled member12 can be visualized in the unbending channel via the opening ofguide template66 alongexternal wall55bto confirm proper positioning. The forward aspect of theangled member12 can be placed in theunbending channel64 simultaneously with matching the angled member to theguide template66 by first placing the forward aspect in the guide template to confirm the correct match and then moving the forward aspect along the guide template and into the unbending channel. Alternatively, theangled member12 matched to theguide template66 can be positioned in theunbending channel64 by introducing thedistal end26 of the angled member directly into theunbending slot70 via its open end and moving the angled member longitudinally until thedistal end26 abutsabutment wall72.
In a method of straightening or unbending the angled[0070]tissue cutting instrument10 using thestraightening tool50, theangled member12 is first compared to theguide template66 and, in the event that the angled member indeed matches the guide template, is then positioned in the unbending channel corresponding to the matching guide template. Where the angled member does not match the guide template, as where the forward aspect of the angled member fails to visually match and/or physically mate with or complementary fit within the guide template, the associated unbending channel is rejected for use in straightening the angled member. The forward aspect of the angled member is then compared to one or more other different guide templates of the same or a different straightening tool or tools until a correct match is established between the forward aspect and a guide template, and the forward aspect is positioned in the unbending channel corresponding to the matching guide template.
Matching the angled member to the correct guide template and positioning the forward aspect in the unbending channel corresponding to the matching guide template can be executed by a single person using one hand to grasp the handle of the tool and the other hand to manipulate the angled member. The angled[0071]outer member12 can be matched to a guide template and positioned in the associated unbending channel with theinner member14 withdrawn from the angled outer member, where the design of the instrument permits withdrawal or removal of the inner member from the outer member as shown by solid lines in FIG. 6, or with theinner member14 disposed within theouter member12 as shown in dotted lines in FIG. 6. The inner and outer members may be uncoupled from the poweredsurgical handpiece84 prior to matching and/or positioning, or the inner and outer members may remain coupled to the poweredsurgical handpiece84 during matching and/or positioning as also shown in FIG. 6.
When the[0072]angled member12 is positioned in theunbending channel64 withdistal end26 in abutment withabutment wall72, the outer or external diameter of the angled member is received in theconfinement passage68 with a close fit, and thedistal length portion22 is confined against radial movement, i.e. movement in a direction radial to its centrallongitudinal axis30. Thedistal length portion22 of the angled member is thusly coaxially aligned with the confinement passage, and thebend20 and part of theproximal length portion18 are disposed in unbendingslot70 along the upper surface of theunbending channel64. Thebend20 is disposed externally of theconfinement passage68, and theproximal length portion18 extends upwardly from thebend20 relative to thedistal length portion22 and extends externally from thepositioning block54 through the open end of unbendingslot70. Of course, the straighteningtool50 andangled member12 may be inverted1800 or otherwise rotated for use in a position other than the position shown in FIGS. 3 and 6.
Once the[0073]distal length portion22 ofangled member12 is positioned in theunbending channel64 and confined in theconfinement passage68 with thedistal end26 in abutment with theabutment wall72, theproximal length portion18 ofangled member12 that extends externally from theunbending slot70 is forcefully moved, pivoted or rotated, typically manually with the hand, in a direction opposite thebend20, i.e. downwardly looking at FIG. 6, until theproximal length portion18 contacts or abuts thecontact surface80 to reverse bend themember12 as shown in dotted lines in FIG. 6. Reverse bending themember12 imparts a positive bend angle to themember12 opposite theinitial bend20. As theproximal length portion18 is pivoted into contact withcontact surface80, it is confined between theinternal side walls78aand78bof the unbending slot against movement transverse to the direction of pivotal movement to prevent misalignments and distortion. The curved configuration of thecontact surface80 mates with the external or outer curvature of themember12 to ensure proper abutment of themember12 with the contact surface. The constraint provided by theconfinement passage68 acts as a fulcrum about which themember12 is pivoted without damaging theopening28 and/or thecutting edge46 thereof. Where theinner member14 is disposed within the angledouter member12 during straightening, the flexible region of the inner member allows the inner member to follow or conform to the configurations of the outer member during straightening, and the cutting edge and/or opening of the inner member is also not damaged.
Once the[0074]proximal length portion18 has been moved into contact withcontact surface80, pivoting force or pressure on the proximal length portion in the direction opposite theinitial bend20 is released, and the proximal length portion will spring back a small predictable or estimatable amount away fromcontact surface80 in the direction of the initial bend, as shown in dotted lines and by the arrow in FIG. 6, due to the spring memory characteristics of the angled member. Theunbending slot70 and, in particular, theside walls78aand78bthereof, confine theangled member12 against movement transverse to the direction of spring back movement such that proper alignment is maintained. The angle ofcontact surface80 ensures that themember12, after springing back fromcontact surface80, assumes a longitudinally or axially straight configuration in which themember12 is completely longitudinally or axially straight as shown in dotted lines in FIG. 6 or is substantially completely longitudinally or axially straight with only a slight positive bend, curve or angle in the same direction as the initial bend. Accordingly, “unbending” and “straightening” as used herein refer to a complete unbending or straightening in which the angled member is rendered completely longitudinally or axially straight or a substantially complete unbending or straightening in which the angled member is rendered substantially completely longitudinally or axially straight. The extent to which theproximal length portion18 springs back and, therefore, the size of any residual positive bend, curve or angle, will depend on the spring memory characteristics of the particular angled member.
Straightening or unbending of the[0075]angled member12 is accomplished using thestraightening tool50 in a minimal number of simple procedural steps. Once straightening has been accomplished, the angled member need only be withdrawn from the tool by pulling the angled member away from the straightening tool in the longitudinal or axial direction. If necessary, the straightened angled member is reassembled with the inner member to form a longitudinally or axially straight tissue cutting instrument, and the reassembled inner and outer members are reattached to the powered surgical handpiece. Of course, where the poweredsurgical handpiece84 remains attached to the inner and outer members during straightening, the longitudinally straight tissue cutting instrument is ready for further use upon withdrawal from the straightening tool.
An alternative straightening or[0076]unbending tool150 is depicted in FIGS. 7-11 and is characterized by a plurality of different unbending channels each having a guide template. Thetool150 comprises handle152, afirst positioning block154 extending fromhandle152 in a first direction and asecond positioning block154′ extending fromhandle152 in a second direction opposite the first direction. Handle152 comprises an elongatecylindrical section156 extending between the first and second positioning blocks154,154′ and provided with external ridges or grooves to facilitate grasping. The positioning blocks154 and154′ are similar topositioning block54 except thatpositioning block154 has twounbending channels164aand164btherein andpositioning block154′ has twounbending channels164a′and164b′ therein. Although each positioning block oftool150 is shown with two unbending channels, it should be appreciated that eachpositioning block154 and154′ could be provided with one or more unbending channels. Theunbending channels164a,164b,164a′ and164b′ are similar tounbending channel64 but are different from each other since theunbending channels164a,164b,164a′ and164b′ are designed for differentangled members112a,112b,112a′ and112b′, respectively, having different longitudinal profiles along their forward aspects.Tool150 has a guide template for each unbending channel, thetool150 havingguide templates166a,166b,166a′ and166b′ corresponding to theunbending channels164a,164b,164a′ and164b′, respectively. Theguide templates166a,166b,166a′ and166b′ are similar to guidetemplate66 but are different from each other in accordance with the different longitudinal profiles ofangled members112a,112b,112a′ and112b′, respectively.
The[0077]guide template166aforunbending channel164ais disposed alongexternal sidewall155aofpositioning block154 and has a longitudinal profile corresponding, matching or complementary to the longitudinal profile of the forward aspect ofangled member112ahaving by way of example an outer diameter of 4.0 mm and a bend angle A of 12°. Also, theconfinement passage168aofunbending channel164aand the second length section ofguide template166ahave a length corresponding to the working length ofangled member112a, and the upper surface ofunbending channel164afollows the longitudinal profile of the forward aspect. Theunbending channel164aconforms to the longitudinal profile of theguide template166aas explained above for unbendingchannel64 and guidetemplate66. Thecontact surface180aforunbending channel164aextends at an angle to theconfinement passage168a, and the angle is selected to reverse bend angledmember112aan amount sufficient to straightenouter member112aafter spring back. Theguide template166acommunicates with theunbending channel164aas described above forguide template66 andunbending channel64.
The[0078]guide template166bfor unbendingchannel164bis disposed alongexternal side wall155bofpositioning block154 and has a longitudinal profile corresponding to the longitudinal profile of the forward aspect ofangled member112bhaving by way of example an outer diameter of 4.5 mm and a bend angle A of 45°. Also, theconfinement passage168bofunbending channel164band the second length section ofguide template166bhave a length corresponding to the working length ofangled member112b. As best seen in FIG. 9, theguide template166bis longer thanguide template166a. Thecontact surface180bfor unbendingchannel164bextends at an angle fromconfinement passage168b, and the angle ofcontact surface180bis selected to reverse bend angledmember112ban amount sufficient to straightenouter member112bafter spring back. Theunbending channel164bconforms to the longitudinal profile of theguide template166b, with the upper surface thereof following the longitudinal profile of the forward aspect ofangled member112b. Theunbending channels164aand164bare disposed side by side in thepositioning block154 in parallel arrangement, with the planes of theunbending channels164aand164bbeing laterally offset on opposite sides of a central longitudinal axis oftool150 as best seen in FIG. 10.
The[0079]guide template166a′ for unbendingchannel164a′ is disposed alongexternal side wall155a′ ofpositioning block154′ and has a longitudinal profile corresponding to the longitudinal profile of a forward aspect ofangled member112a′ having an outer diameter of 4.0 mm and a bend angle A of 40°. Also, theconfinement passage168aofunbending channel164a′ and the second length section ofguide template166a′ have a length corresponding to the working length ofangled member112a′, and the upper surface ofunbending channel164a′ conforms to the longitudinal profile ofguide template166a′ as well as the longitudinal profile of the forward aspect ofangled member112a′. Thecontact surface180a′ for unbendingchannel164a′ extends at an angle to theconfinement passage168a′, and this angle is selected to reverse bend angledmember112a′ an amount sufficient to straightenangled member112a′ after spring back.
The[0080]guide template166b′ for unbendingchannel164b′ is disposed alongexternal side wall155b′ ofpositioning block154′ and has a longitudinal profile corresponding to the longitudinal profile of a forward aspect ofangled member112b′ having an outer diameter of 3.5 mm and a bend angle A of 60°. Theconfinement passage168b′ for unbendingchannel164b′ and the second length section ofguide template166b′ have a length corresponding to the working length ofangled member112b′. Theunbending channel164b′ conforms to the longitudinal profile of theguide template166b′, with the upper surface of theunbending channel164b′ following the longitudinal profile of the forward aspect ofangled member112b′. Thecontact surface180b′ for unbendingchannel164b′ extends at an angle to the confinement passage168′. The angle of thecontact surface180b′ is selected to reverse bend angledmember112b′ an amount sufficient to straightenangled member112b′ after spring back. As shown in FIG. 9, thepositioning block154′ is representative of a positioning block in which bothunbending channels164a′,164b′ and theguide templates166a′,166b′ therefor are substantially the same length. Theunbending channels164a′ and164b′ are arranged inpositioning block154′ similar to the arrangement ofunbending channels164aand164binpositioning block154.
The[0081]unbending tool150 is used in a manner similar to that described fortool50 in that theguide templates166a,166b,166a′ and166b′ may be used to match theangled members112a,112b,112a′ and112b′ with the appropriateunbending channels164a,164b,164a′ and164b, respectively, prior to straightening by visually comparing the longitudinal profiles of the forward aspects of the angled members with the guide templates and/or by positioning the forward aspects of the angled members in the guide templates with a complementary, mating or close fit. Accordingly, an individual straightening tool can be used to straighten various different angled members having different longitudinal profiles including different outer diameters, bend angles and/or working lengths, and the guide templates ensure that each angled member is matched to the appropriate unbending channel. Thestraightening tool150 may be used to match the forward aspect of an angled member of an angled tissue cutting instrument with a guide template of the straightening tool and thereafter unbend or straighten the angled member using the unbending channel corresponding to the matching guide template as explained above. The step of matching the forward aspect of the angled member with the guide template may include a visual side-by-side comparison without inserting the forward aspect in the guide template but will preferably include placing the forward aspect within the guide template and thereafter moving the forward aspect along the guide template into the associated unbending channel.
The straightening procedure may be performed during a surgical procedure wherein an angled tissue cutting instrument and a[0082]straightening tool50,150 having a guide template matching the angled member of the instrument are provided as a tissue cutting instrument system or apparatus. Matching of the angled member to the guide template is accomplished as described above. The angled tissue cutting instrument is used during the surgical procedure to remove anatomical tissue at an operative site, the angled tissue cutting instrument is subsequently straightened or unbent during the surgical procedure to obtain a longitudinally or axially straight tissue cutting instrument, and the straight tissue cutting instrument is thereafter used in the surgical procedure to further remove anatomical tissue. By using an angled tissue cutting instrument in which the outer angled member is supplied with a manufactured pre-formed bend, the instrument is ready for use without any bending of the outer member being needed to impart an angle thereto prior to performing the surgical procedure.
FIGS. 12 and 13 are illustrative of a surgical procedure, particularly a combined tonsillectomy and adenoidectomy (T&A) procedure, using a tissue cutting instrument system including the angled[0083]tissue cutting instrument10 and thestraightening tool50. FIG. 12 illustrates the angled tissue cutting instrument oradenoid blade10 inserted through a patient's mouth to perform an adenoidectomy. The distal end of the angledtissue cutting instrument10 is introduced into the nasopharynx with theopening28 facing anadenoid96. The adenoidectomy is initiated in the anterior nasopharynx, near the choana. Theinner member14 is rotated within theouter member12 by the poweredsurgical handpiece84, and the cutting edges44 and46 remove adenoid tissue. Removal of adenoid tissue is initiated using a light touch with the adenoid blade, with tissue removal being accomplished by moving the blade side-to-side and/or sweeping the blade anterior to posterior. Sweeping the blade anteriorly to posteriorly is particularly effective along the torus tubarius. The adenoid blade is predictably sharp for every case, allowing a precise progressive removal of adenoid tissue while simultaneous suction or aspiration evacuates blood and tissue from the operative site for enhanced visualization. Tissue at the superior choana and along the torus tubarius can be shaved away to effect a more thorough adenoidectomy which minimizes the potential for tissue regrowth and symptom recurrence. Continuous suction through the inner member keeps the surgical field visible while tissue is removed from difficult areas such as the superior choana and along the posterior torus tubarius. The precise shaving action of the adenoid blade removes well-defined portions of tissue exactly where the blade is placed. The increased surgical accuracy allows easy removal of hypertrophic adenoid tissue from the posterior nasal cavity and along the torus. The curved, bent or angled configuration of the adenoid blade greatly enhances access to the operative site.
Upon completion of the adenoidectomy, the[0084]instrument10 is withdrawn from the patient's mouth, and theouter member12 is compared to theguide template66 to confirm proper matching as described above. Initial matching of the outer member to the guide template may be performed prior to surgery. The straighteningtool50 will be sterile so that theinstrument10 is not contaminated. Theouter member12 is straightened or unbent using the unbending channel associated with the matching guide template as described above to obtain a longitudinally or axially straighttissue cutting instrument10. Given the fail-safe manner in which matching is accomplished, use of the most appropriate unbending channel is assured. The straighttissue cutting instrument10 is inserted in the patient's mouth to perform a tonsillectomy as shown in FIG. 13. Theopening28 of theouter member12 is positioned adjacent atonsil97, and the straight longitudinal profile of thetissue cutting instrument10 enhances access to thetonsil97. Theinner member14 is rotated within theouter member12 via the poweredsurgical handpiece84, and the cutting edges44 and46 remove anatomical tissue of the tonsil while suction or aspiration is effected through theinner member14. Upon completion of the tonsillectomy, the straighttissue cutting instrument10 is withdrawn from the patient's mouth.
An alternative angled[0085]tissue cutting instrument210 for use with straighteningtools50,150 is shown in FIG. 14.Instrument210 is similar toinstrument10 except that theopening228 ofouter member212 faces in the direction of the center of curvature forbend220. The angledtissue cutting instrument210 corresponds to theRAD® 40 Curved Blade of Medtronic Xomed Surgical Products and has an angle A of about 40° between the centrallongitudinal axis224 ofproximal length portion218 and the centrallongitudinal axis230 ofdistal length portion222. The angledtissue cutting instrument210 may be provided with an angle A′ of about 60° between the centrallongitudinal axis224 ofproximal length portion218 and the centrallongitudinal axis230 ofdistal length portion222 as shown in dotted lines in FIG. 14 and as corresponds to theRAD 60 X-TREME™ Curved Blade of Medtronic Xomed Surgical Products. The angledtissue cutting instrument210 is particularly advantageous for use as a sinus blade in sinus surgery to access the frontal recess and maxillary sinus, for ethmoid and frontal recess surgery, maxillary polyp removal, uncinectomy and antrostomy, for example. Depending on whether the angle A ofouter member212 is 40° or 60°, theouter member212 may be straightened using theunbending channels164a′ or164b′ oftool150 as determined via matching of the longitudinal profile of the forward aspect ofangled member212 with the correct guide template as described above.
FIGS. 15 and 16 depict a surgical procedure including a sinus procedure performed using a tissue cutting instrument system or apparatus comprising angled tissue cutting instrument or[0086]sinus blade210 and straighteningtool150. As shown in FIG. 15, the angledtissue cutting instrument210 is introduced in a patient's nostril to position theopening228 ofouter member212 adjacent anatomical tissue to be removed in the sinus. As an example, theopening228 is shown positioned in themaxillary sinus98, access to which is facilitated by the angled longitudinal configuration or profile of the blade. Theinner member214 is rotated within theouter member212 via the poweredsurgical handpiece84, and the cutting edges244 and246 are used to remove anatomical tissue of the maxillary sinus. Suction or aspiration may be accomplished through theinner member214 as described above for angledtissue cutting instrument10. The angledtissue cutting instrument210 is then removed from the patient's nostril and is straightened using the unbending channel oftool150 corresponding to the guide template oftool150 that has been matched to the longitudinal profile ofouter member212 along its forward aspect. The thusly straightenedtissue cutting instrument210 is inserted in the patient's nostril as depicted in FIG. 16, and theinner member214 is rotated within theouter member212 to removeadditional sinus tissue100 in the sinus with the cuffing edges244 and246. When tissue removal using the straightenedtissue cutting instrument210 is complete, theinstrument210 is removed from the nostril.
In order to enhance the precision, control and efficacy of unbending the angled member of an angled tissue cutting instrument, it is advantageous for the confinement passage to be designed to receive the outer diameter of the angled member with a snug or close fit, for the outer diameter of the angled member to be closely confined between the internal side walls of the unbending slot, and for the length of the confinement passage to closely correspond to the working length of the angled member. In addition, it is preferred that the angle of the contact surface be selected in accordance with the bend angle and/or spring properties of the angled member, making it desirable to provide contact surfaces at different angles for angled members of different initial bend angles and/or spring back properties to effect complete straightening of the angled members or as close as possible to a complete straightening after spring back. Given the potential for numerous different angled tissue cutting instruments having outer members of different outer diameters, working lengths and/or bend angles, it is desirable to provide an unbending channel optimally designed for unbending an angled member of particular bend angle, outer diameter, working length and/or spring properties.[0087]
The guide templates ensure a correct match between a particular angled member and an optimal unbending channel therefor, and correct matching is facilitated since the longitudinal profiles of the guide templates correspond to the actual longitudinal profiles of the angled members undergoing comparison or matching with the guide templates. Angled members are straightened or unbent with greater precision, accuracy and control since each angled member may be straightened using the optimal unbending channel for the particular angled member. Each unbending channel may have its contact surface oriented at the optimal angle for straightening the particular angle member while accounting for spring back of the angled member. The guide templates communicate with the corresponding unbending channels and the properly matched angled members can be positioned in the unbending channels through the guide templates for ease of use and to ensure proper positioning of the angled members in the unbending channels. The angled members cannot be inserted through their corresponding guide templates in anything but the correct position and orientation, thereby eliminating trial and error positioning and incorrect unbending. A single unbending tool can be used to straighten a plurality of angled members having different longitudinal profiles.[0088]
In accordance with the present invention, various types of angled tissue cutting instruments can be straightened including rotary tissue cutting instruments as shown herein as well as oscillatory and reciprocatory tissue cutting instruments with or without an aspiration passage and with or without an irrigation passage. Angled tissue cutting instruments may be straightened using a minimal number of simple procedural steps capable of being performed by one person without extraneous equipment and in a brief amount of time. The ease, rapidity and accuracy with which angled tissue cutting instruments can be straightened may make it more desirable and advantageous to straighten an angled tissue cutting instrument during a surgical procedure for further use in the surgical procedure as a longitudinally straightened tissue cutting instrument rather than switching from an angled tissue cuffing instrument to another different longitudinally straight tissue cutting instrument. The outer members of the angled tissue cutting instruments can be straightened with the inner members withdrawn therefrom, the inner members disposed therein and with or without the powered surgical handpiece coupled with the inner and outer members. The openings in the outer members and the cutting edges, where provided in the outer member, are not damaged as a result of straightening. The openings and/or cuffing edges of the inner members are also not damaged where the inner members remain within the outer members during straightening. Proper positioning of the angled members in the unbending channels is easily accomplished by abutment of the distal ends of the angled members with the abutment walls and proper positioning is facilitated by inserting the angled members into the unbending channels via the guide templates. Straightening of the angled members is effected without deformation, kinking and/or misalignments, since the angled members are constrained by the confinement passages and guided by the unbending slots. Straightening of the outer members is controlled via abutment of the proximal length portions with the contact surfaces such that trial and error adjustments are not necessary. The straightening tools are sterilizable for repeated use or may be disposable for single patient use. The straightening tools are without moving parts and small recesses such that the effectiveness and reliability of sterilization is enhanced. Surgical procedures in which it is desirable to employ both angled and straight tissue cutting instruments are facilitated. Use of the most optimal blade configurations as well as the most optimal distal end cutting configurations for tissue removal during surgical procedures is promoted. The cost and time for surgical procedures and the required number of tissue cutting instruments for surgical procedures may all be reduced. The straightening tools are particularly advantageous for use in T&A procedures, sinus procedures and laryngeal procedures but may be used to straighten angled tissue cutting instruments in other surgical procedures. In the methods of the present invention, suction and/or irrigation may be accomplished via the tissue cutting instruments.[0089]
Inasmuch as the present invention is subject to many variations, modifications and changes in detail, it is intended that all subject matter discussed above or shown in the accompanying drawings be interpreted as illustrative only and not be taken in a limiting sense.[0090]